# Point-of-care and decentralised cell manufacturing

Source: https://onco.cc/technologies/point-of-care-cell-manufacturing/  
OnCo record `point-of-care-cell-manufacturing` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Making CAR-T cells at or near the hospital instead of shipping cells to a central factory and back.

## Summary

Academic centres (Sheba, Hospital Clínic Barcelona's ARI-0001, several Chinese and Indian programmes) and companies (Cellares 'Smart Factories', Orgenesis, Galapagos' decentralised model) manufacture cell therapies close to the patient, cutting vein-to-vein time to about a week and cost substantially. Regulators are working out how to license many small sites against one product specification.

## Fields

- Kind: Technology
- Status: emerging
- Last checked: 2026-09-08
- Tags: supporting
- Principle: Standardised closed platforms plus centralised quality oversight and digital batch records allow the same process to run at many sites.
- Strengths: Days rather than weeks to product; Lower cost; Access for hospitals far from central plants
- Limitations: Regulatory model immature outside a few jurisdictions; Site-to-site comparability; Vector supply still centralised

## Sources

- FDA guidance: considerations for the development of CAR T cell products: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-development-chimeric-antigen-receptor-car-t-cell-products

## Connected records

- fronts: [Cell Therapy](https://onco.cc/fronts/cell-therapy/)
- technologies: [Autologous CAR-T manufacturing, batch by batch](https://onco.cc/technologies/car-t-manufacturing-process/), [CAR-T cell therapy](https://onco.cc/technologies/car-t/), [Closed automated cell-therapy manufacturing](https://onco.cc/technologies/closed-automated-cell-manufacturing/)
- companies: [Cellares](https://onco.cc/companies/cellares/), [Galapagos](https://onco.cc/companies/galapagos/), [Immuneel Therapeutics](https://onco.cc/companies/immuneel/), [ImmunoACT](https://onco.cc/companies/immunoact/), [Miltenyi Biotec](https://onco.cc/companies/miltenyi-biotec/)
- people: [Rahul Purwar](https://onco.cc/people/purwar-rahul/)
- key papers: [UCART19: the first gene-edited, donor-derived CAR-T cells in children and adults with relapsed B-cell ALL](https://onco.cc/key-papers/paper-ucart19-allogeneic-car-t-lancet-2020/)
- terms: [Vein-to-vein time and manufacturing slots](https://onco.cc/terms/vein-to-vein-time/)
- institutions: [Advanced Centre for Treatment, Research and Education in Cancer](https://onco.cc/institutions/actrec/), [Department of Biotechnology, Government of India](https://onco.cc/institutions/dbt-india/), [Indian Institute of Technology Bombay](https://onco.cc/institutions/iit-bombay/)
- drugs: [Talicabtagene autoleucel](https://onco.cc/drugs/talicabtagene-autoleucel/), [Varnimcabtagene autoleucel](https://onco.cc/drugs/varnimcabtagene-autoleucel/)
- trials: [IMAGINE (varnimcabtagene autoleucel, Immuneel)](https://onco.cc/trials/imagine-varnimcabtagene/), [Talicabtagene autoleucel (NexCAR19) phase 1/2](https://onco.cc/trials/talicel-phase-1-2/)

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